Surgical devices and methods

ABSTRACT

A medical introducer includes an elongated tubular member having a proximal end, a distal portion, and a central lumen extending from the proximal end to a distal port in the distal portion. A frame structure is coupled to the distal portion of the elongated tubular member, where frame structure supports the distal portion of the elongated tubular member in a tapered shape and alternatively in a non-tapered shape. The elongated tubular member may include a rigid outer tube and a rigid inner tube carried in an interior lumen of the outer tube. The distal portion is typically a reinforced elastomeric tubular extension of the outer tube, and the reinforced elastomeric tubular extension may have a conical shape.

This application claims the benefit of provisional patent applicationNo. 62/584,075 (Attorney Docket No. 42005-711.101), filed on Nov. 9,2017, and of provisional patent application No. 62/584,550 (AttorneyDocket No. 42005-712.101), filed on Nov. 10, 2017, the full disclosuresof which are incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to devices and methods for resecting andremoving tissue from an interior of a patient's body, for example in atransurethral resection of prostate tissue to treat benign prostatichyperplasia.

Electrosurgical cutting devices often comprise a shaft or sleeve havinga tissue extraction lumen with one or more radio frequency (RF) cuttingblades arranged to resect tissue which may then be drawn into theextraction lumen, often via vacuum assistance through a cutting window.Most such electrosurgical tissue cutting devices rely on manuallyengaging the cutting window against the target tissue to be resected.While such manual engagement is often sufficient, in other cases, suchas in laparoscopic procedures having limited access and field of view,the target tissue can be difficult to visualize prior to resection and,in particular, it can be difficult to assure that the optimum targetsite has been engaged by the cutting window. For these reasons, it wouldbe desirable to provide improved electrosurgical cutting tools havingimproved visibility and ability engage and immobilize tissue prior tocutting and to extract the tissue from tools after cutting.

For resection of remote tissue sites, such as the prostate, it isusually desirable to introduce the surgical cutter through a tubularintroducer device. Though such tubular introducers can be advanced“blind,” i.e., without direct optical visualization, it is frequentlyadvantageous to provide such introducers with direct visualization. Forexample, it would be desirable to use an endoscope to observe theurethra while transurethrally advancing an introducer sheath forsubsequent resection of the prostrate. Once the introducer sheath is inplace and the surgical cutter has been introduced, however, it willstill be necessary to move a cutter element on the surgical cutter toresect the tissue. Heretofore, this has typically been accomplished bymanually reciprocating a cutter assembly on the tissue resectingapparatus. Manual resection, while generally effective, can be difficultto control and, in particular, can be difficult to coordinate with otheraspects of the resection procedure, such as applying RF power, applyinga vacuum to aspirate tissue fragments and debris, and the like.

For these reasons, it would be desirable to provide improved apparatus,systems and methods for resecting tissue in prostatectomies and otherprocedures. It would be particularly desirable to provide apparatus,systems and methods which provide improved control of tissue resectionincluding but not limited to enhanced coordination of cutter movementcontrol, cutting power control, vacuum aspiration control, and the like.At least some of these objectives will be met by the inventionsdescribed below.

2. Description of the Background Art

Commonly owned patents and published applications include U.S. Pat. No.10,004,556; US 2018-0280077; US 2018-0221054; US 2017-0333119; US2017-0333120; US 2017-0105607; and US 2017-0105748.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a view of a tissue resecting device and a block diagram ofsystems and operating components corresponding to the invention.

FIG. 2 is a perspective view of the working end of the resecting deviceof FIG. 1 showing an asymmetric ceramic housing and moving electrodethat is adapted to sweep across a tissue-receiving window.

FIG. 3 is another perspective view of the working end of FIG. 2 from adifferent angle.

FIG. 4A is a schematic view of the working end of FIGS. 2-3 interfacingwith tissue targeted for resection under endoscopic vision.

FIG. 4B is a schematic view of a working end of a prior art tubularcutting device used in a hypothetical resection procedure.

FIG. 5 is another schematic view of the working end of FIGS. 2-3 beingused to resect targeted tissue to a significant depth from the organsurface.

FIG. 6 is a perspective view of a distal dielectric housing of a workingend similar to that of FIGS. 2-3 showing window sides with ledges forreceiving the electrode at the ends of its movement in a sweeping arc.

FIG. 7A is a perspective view of a distal ceramic housing of a workingend similar to that of FIG. 6 with the distal tip of the moveableelectrode adapted to move in a constraining slot or channel.

FIG. 7B is a perspective view of an alternative ceramic housing similarto that of FIG. 7A with the distal tip of the moveable electrode adaptedto pivot or rotate in a bore or pivot.

FIG. 8 is a perspective view of a tissue resecting device that includesa motor drive for moving the shaft assembly and working end in areciprocating mode relative to the handle.

FIG. 9A is a perspective view of the working end of the device of FIG. 8showing an endoscope carried by the shaft assembly and the endoscopefield of view.

FIG. 9B is a perspective view of the working end of the device of FIG.9A from another angle.

FIG. 10A is a side view of the tissue resecting device of FIG. 8 withthe reciprocating shaft assembly and working end at the distal end of anextending stroke relative to the handle.

FIG. 10B is a side view of the tissue resecting device of FIG. 10A withthe reciprocating shaft assembly and working end at the proximal end ofa retracting stroke relative to the handle.

FIG. 11 is a sequential view of the tissue resecting device of FIGS.10A-10B showing retracting and extending strokes and a method ofactivating and de-activating the negative pressure source and thedelivery of RF current to the electrode in different portions of theretracting and extending strokes.

FIG. 12A is a sectional schematic view of the working end with themoving electrode resecting tissue.

FIG. 12B is a sectional schematic view of the working end similar tothat of FIG. 12A with a stationary electrode coagulating tissue.

FIG. 13 is a perspective view of another variation of a resecting deviceof similar to that of FIG. 1 with an integrated introducer sleeveassembly.

FIG. 14A is an enlarged view of the distal end portion of the resectingdevice of FIG. 13 showing an expandable, resilient structure in atapered shape for introduction into a patient's body.

FIG. 14B is another view of the distal end portion of the resectingdevice of FIG. 14A showing the resilient structure in a second, expandedcylindrical shape for introduction of a resecting componenttherethrough.

FIG. 15 is a view of the distal end portion of FIG. 14B in its expandedcylindrical shape with a resecting component extending distally beyondthe resilient structure.

FIG. 16 is an end view of the distal end portion of the resilientstructure of FIG. 14B showing various flow channels therein.

FIG. 17 is a sectional view of the distal end portion of the resectingdevice and resilient structure of FIG. 14B taken along line 17-17 ofFIG. 14B.

FIG. 18 is a view of the distal end portion of the resecting device ofFIG. 15 showing the working end of the resecting component and furtherillustrating the surface area of the sweep of the oscillating RFelectrode.

FIG. 19 is another view of the distal end portion of the resectingdevice of FIG. 18 showing the stroke of the resecting component andagain illustrating the surface area of the sweep of the oscillating RFelectrode in combination with the stroke.

FIG. 20 is a view of the distal end portion of a resecting devicesimilar to that of FIGS. 14A-14B with another variation of a resilientstructure having a contracted, tapered shape that can be actuated to anexpanded, cylindrical shape.

FIG. 21 is a perspective view of the distal end of a resecting devicewith another variation of a resilient structure similar to that of FIG.20.

FIG. 22 is a perspective view of the distal end of a resecting devicewith yet another variation of a resilient structure similar to that ofFIG. 21 within asymmetric shape having a distal opening offset from thecenterline of the instrument shaft.

FIG. 23 is a perspective view of the distal end of another variation ofa resilient structure similar to that of FIGS. 14A-14B which includes anadditional elastomeric structure that is deformable to provide anexpanded annular shape for sealing a body passageway.

FIG. 24 is a sectional view of the resilient structure of FIG. 23 withthe elastomeric structure deformed to an expanded annular shape.

SUMMARY OF THE INVENTION

The present invention provides apparatus, systems, and methods forperforming electrosurgical resections in minimally invasive procedures.While the apparatus, systems, and methods are particularly suitable forperforming transurethral resection of the prostate (often referred to asTURP), they will also find use in a variety of other laparoscopic andother endoscopic and endosurgical procedures. The apparatus comprisesmotor-driven cutters, where the motors are configured to drive both ashaft of the cutter and a cutter electrode, either independently,contemporaneously, or selectively independently and contemporaneously.The systems comprise the cutters together with a digital or othercontroller configured to coordinate movements of the shaft, electrodes,and other external components such as a radiofrequency power supply(e.g. by selecting a cutting or a coagulation waveform, power, timing,etc.), a negative pressure source, and the like. The methods of thepresent invention comprise using the apparatus and systems as justdescribed for prostatectomies and other tissue resection procedures.

In a first aspect, the present invention provides a tissue resectingdevice comprising a shaft assembly movably attached to a handle andhaving a longitudinal axis. A housing is secured to a distal end of theshaft and has a window configured to be fluidly coupled to a negativepressure source. An electrode is disposed in the housing and configuredto move relative to the window, and at least one motor in the handle isadapted to both (1) move the shaft assembly in an axial stroke relativeto the handle and (2) move the electrode across the window.

In specific embodiments and examples of the tissue resecting device, theat least one motor is adapted to move the shaft assembly and theelectrode contemporaneously, i.e. at the same time. In other specificembodiments and examples, the at least one motor is adapted toselectively move either the shaft assembly or the electrodeindividually. In many embodiments, the at least one motor will beadapted to move the shaft assembly and electrode both contemporaneouslyand individually at different times during a procedure. In stilladditional specific examples, the motor will be adapted to move theelectrode at a fixed speed or rate relative to the window, e.g. at arate greater than 1 cycle per second (CPS), often greater than 5 CPS.The motor may be still further adapted to reciprocate the shaft assemblyat a rate greater than once every two seconds, frequently at a rategreater than once every second.

The shaft and/or the electrode may be operated manually and/orautomatically. That is, the user may be able to manually initiate the atleast one motor to move the electrode in the housing relative to thewindow and/or to manually activate the at least one motor to reciprocatethe shaft in an axial stroke relative to the handle. Even when beingoperated manually, the tissue resecting device will usually be operatedthrough an interface (typically including a radiofrequency (RF) powersupply) which may provide for specific operational parameters, oftenfixed or manually adjustable parameters, such as stroke times, powerlevels, RF waveforms, and the like, without having feedback controlcapability.

Often, however, the tissue resecting device will be provided as part ofa tissue resecting system which further comprises a controller which isconfigured to operate not only the motor, but usually also a RF powersource which is coupled to the electrode and also a negative pressuresource which may be coupled to the window in the housing. The controllermay be further configured or adapted to automatically or manuallycontrol at least one motor to stop movement of the electrode in aselected position relative to the window. Alternatively or additionally,the controller may be adapted to stop the electrode in the center of thewindow. Alternatively or additionally, the controller may be adapted tostop the electrode at an end of the window.

The controller may be adapted in a variety of other different controlprotocols. For example, the controller may be adapted to control the atleast one motor to provide a single movement cycle of the electrode backand forth across the window. That is, the user may be able to cause thecontroller to initiate only a single pass of the electrode over thewindow in order to achieve a controlled cutting of tissue. In otherinstances, the controller may be adapted to control the at least onemotor to stop axial movement of the shaft in a selected axial position.The controller may be further adapted to control the at least one motorto provide a single movement of the shaft in retracting and/or extendingstroke. Additionally, the controller will usually be configured tocontrol and coordinate the delivery of negative pressure from thenegative pressure source to the housing window and to actuate the atleast one motor, usually contemporaneously.

In still other aspects of the control systems of the present invention,the controller may be configured to modulate the negative pressuresource in response to movement of the shaft assembly. That is, thenegative pressure may be applied only, for example, when the shaft isextend and/or may be deactivated only when the shaft is retracted.

In still further aspects of the systems of the present invention, thecontroller may be configured to modulate the negative pressure source inresponse to movement of the electrode relative to the window. Forexample, the controller may be configured to active or deactivate the RFsource in response to movement of the electrode relative to the window.Still additionally, the controller may be configured to activate ordeactivate the RF source to deliver a cutting current waveform or acoagulation waveform to the electrode.

In a second aspect, a tissue resecting system comprises a handle, anelongate shaft, an electrode, and a controller. The elongate shaft isreciprocally connected to the handle and extends along a longitudinalaxis to a working end. The working end is movable in a stroke between afirst axial position and a second axial position relative to the handle.The electrode is disposed at the working end of the shaft and isconfigured to be coupled to an RF source. An aspiration channel isformed in the elongate shaft and communicates with a window in theworking end of the shaft and is configured to be coupled to a negativepressure source. The controller is operatively connected to the RFsource and the negative pressure source and is configured to modulateenergy delivery from the RF source to the electrode and to modulatenegative pressure to the aspiration channel where modulations of bothpressure and energy are in response to an axial position of the workingend in said stroke.

In a third aspect, a method of the present invention for resectingtissue comprises providing an elongate shaft assembly. The elongateshaft assembly includes an electrode proximate a window in a housing. Amotor reciprocates the shaft assembly in a retracting stroke and anextending stroke relative to a handle. The handle is manipulated toposition the electrode against a targeted tissue site, and a negativepressure source may be activated to communicate with the window in theworking end to draw tissue to or through the window. The RF source isthen activated to deliver RF current to the electrode, and the motor iscontrolled to reciprocate the shaft assembly in a retracting stroke toresect tissue. Optionally, the motor may further laterally reciprocateor otherwise drive the electrode in a lateral stroke across the windowto effect tissue resection.

In specific embodiments and examples, the steps of activating thenegative pressure source, activating the RF source, and controlling themotor are performed by a digital or other controller. The methods mayfurther comprise deactivating the negative pressure source at theproximal end of the retracting stroke. The methods may alternatively oradditionally comprise deactivating the RF source at the proximal end ofthe retracting stroke. The methods may still further alternatively oradditionally comprise commencing the extending stroke with the negativepressure source deactivated, commencing the extending stroke with the RFsource deactivated, activating the negative pressure source during aportion of the extending stroke, and/or activating the negative pressureduring a terminal portion of the extending stroke.

In particular aspects of the present invention as described in detailbelow, the devices, systems and methods are particularly configured fortreating the prostate, optionally under endoscopic visualization. Forexample, the systems may comprise a RF source configured to deliver RFcurrent alternatively in a cutting waveform and a coagulation waveformto the electrode, a motor configured to move the electrode, and acontroller configured to operate the motor and RF source in a first modedelivering a cutting waveform while activating the motor to move theelectrode and in a second mode delivering a coagulation waveform afterde-activating the motor to stop the electrode in a selected stationaryposition. Such methods for treating the prostate may comprise providinga treatment device with a shaft extending along a longitudinal axis to adistal portion having a window communicating with an aspiration sourceand a motor driven electrode adapted to move relative to the window. Thewindow is engaged against targeted prostate tissue, and the RF source isoperated in a first mode with a cutting waveform delivered to theelectrode while activating the motor to move the electrode to resecttissue and thereafter operated in a second mode with a coagulationwaveform delivered to the electrode after de-activating the motor tostop the electrode in a selected stationary position to coagulatetissue.

In another aspect of the present invention, a medical device comprisesan elongated tubular member having a proximal end, a distal portion, anda central lumen extending from the proximate end to a distal port in thedistal portion. A frame structure is coupled to the distal portion ofthe elongated tubular member and is configured to support the distalportion in each of a tapered shape and a non-tapered shape. In specificinstances, the tapered shape may be conical (typically frusto-conicalwith an open port defining a narrow, distal end) and the non-taperedshape may be cylindrical. Other tapered shapes, such as a rounded-noseshape, a pyramidal shape, hemispherical, funnel-like, and the like, aswell as other non-tapered shapes, such as those having ellipsoidal,polygonal, and other cross-sectional geometries, may also find use.

In other specific instances, the frame structure may be configured toopen the distal portion of the elongated tubular member to itsnon-tapered shape in response to an internal, radially outwardly actingforce (such as that applied by advancing a tubular or other structuredistally through a lumen of the distal portion) and to resiliently closethe distal portion to its tapered shape in the absence in such aninternal, radially outwardly acting force.

The frame structure will often comprise struts which are embedded in anelastomeric region of the distal portion of the elongated tubularmember, where the struts may have a variety of specific configurations,including zig-zag, serpentine, axially oriented, and the like. In stillother instances, the elastomeric material may be substantiallytransparent to allow better visualization of instruments and tools beingintroduced through the medical device.

In still further specific examples, the elongated tubular member maycomprise an outer tube and an inner tube carried in an interior lumen ofthe outer tube. The inner tube may be configured to axially translatefrom (a) an axially retracted position wherein the frame structure isresiliently closed and the distal portion of the elongated tubularmember is in its tapered shape to (b) an axially extended position wherethe frame structure is open and the distal portion is in its non-taperedstate.

In other specific examples and embodiments, the interior lumen of theelongated tubular member transitions to a central passageway in thedistal portion of the elongate tubular member and extends to the distalport. The central passageway in the distal portion will typically taperto a distal port having a diameter less than a diameter of the interiorlumen proximal of the distal portion when said distal portion is in itstapered shape. Similarly, the central passageway in the distal portionwill typically have a constant diameter equal to a diameter of theinterior lumen proximal of the distal portion when the distal portion isin its non-tapered shape.

In yet other instances and embodiments, the elongated tubular member maycomprise a rigid outer tube and a rigid inner tube carried in aninterior lumen of the outer tube. In such instances, the distal portionmay comprise a reinforced elastomeric tubular extension of the outertube which will often have a conical shape.

In still other examples and instances, the frame structure may comprisea shape memory material having a conical shape memory (i.e. when in itsunstressed condition) and expandable to a cylindrical shape whensubjected to an internally applied, radially outwardly oriented force.The shape memory material may be formed into a variety of geometries,such as a zig-zag ring, a serpentine ring, a plurality of axial strutsjoined to a base ring, a plurality of unconnected axial struts, aplurality of axially extending rings attached to a distal end of theouter tube, and the like.

The central lumen of the elongated tubular member may be configured in avariety of ways for a variety of purposes. For example, the centrallumen may be configured to accommodate an endoscope, an elongated shaftof a treatment device, or for a variety of other purposes. In stillother instances, the elongated tubular member may be configured to beconnected to a negative pressure source. In such instances, the negativepressure source may be specifically configured to connect to an annularspace between an inner surface of the outer tube and an outer surface ofthe inner tube, where the outer tube is usually perforated allowingaspiration through such perforations.

The tubular member may be still further configured for other specificpurposes. For example, the tubular member may include an interiorchannel communicating with the fluid inflow source and/or an innerchannel communicating with a pressure sensor. The medical device mayfurther comprise an actuator for moving the inner tube between aretracted and extended position relative to the outer tube.

In yet another aspect of the present invention, a medical introducercomprises an outer tube having a proximal end, a distal end, and a lumentherebetween. An elastomeric sleeve extends distally from the distal endof the outer tube, where the elastic sleeve usually tapers in a distaldirection from the distal end of the outer tube to a distal port. Aconcentric inner tube is slidably received in the lumen of the outertube, where the inner tube is configured to move between a retractedposition and an extended position. In its retracted position, the innertube does not engage the elastomeric sleeve which is able to remain inits tapered configuration. In contrast, when extended, the inner sleeveengages the elastomeric sleeve to open the elastomeric sleeve to itsnon-tapered shape.

In specific instances, the elastomeric sleeve structure includesreinforcement configured to inhibit axial stretching as the inner tubeis moved between its retracted and extended positions. The reinforcementstructure may take a variety of forms, such as deformable struts coupledto a distal end of the outer tube. In such instances, the deformablestruts are typically metal. In still other instances, the reinforcementmay comprise ribs molded into the elastomeric sleeve. In such instances,the distal port and the elastomeric sleeve may be concentrically alignedwith a central axis of the outer tube. Alternatively, the distal portand the elastomeric sleeve may be radially offset from the central axisof the outer tube.

In still further aspects of the present invention, systems comprisingany of the medical introducers described above may be combined with atool configured to be introduced through a lumen of the concentric innertube. For example, the tool may be an endoscope, an RF tool, or thelike. The systems may further comprise a fluid source connectable to alumen of the inner tube. The systems may still further comprise anegative pressure source connectable to an annular space between theouter tube and the inner tube of the specific embodiments of the medicalintroducer described above.

In a still further aspect of the present invention, a medical introducercomprises an outer tube having a proximal end, a distal end, and a lumentherebetween. A tapered elastomeric sleeve extends distally from thedistal end of the outer tube, and a circumferentially expandableelastomeric sleeve is disposed on the outer tube proximally of thetapered elastomeric sleeve. A concentric inner tube is configured tomove between a retracted and an extended position relative to the outertube. When in its extended position, the inner sleeve will deform thetapered elastomeric sleeve structure outwardly into a cylindrical shape.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates an electrosurgical tissue resecting system 100 foruse in urological procedures to resect tissue that includes anintroducer sleeve or sheath 102 and a hand-held single-use tissueresecting device or probe 105. The resecting device 105 has a handleportion 108 that is coupled to an elongated shaft or extension portion110 that has an outer diameter ranging from about 2 mm to 7 mm, and inone variation is 5 mm in diameter. The shaft 110 extends aboutlongitudinal axis 112 to a working end 115 that is radially asymmetricrelative the shaft 110 and its axis 112 as further described below. Inone variation, the device is adapted for performing a TURP procedure(transurethral resection of prostate) or a bladder tumor resectionprocedure and thus the shaft portion 110 extends about axis 112 with alength suitable for introducing in a transurethral approach to reach thetargeted prostate tissue or bladder tissue.

As will be described below and shown in FIG. 1, the resecting device 105is adapted for introduction through the introducer sleeve 102. Such anintroducer sleeve 102 is adapted to receive a commercially availableendoscope 130 as can be understood from FIG. 1.

Referring to FIGS. 1-3, in general, it can be seen the resecting device105 has an elongated shaft 110 that extends to a distal shaft portion132 that is coupled to an offset resecting housing 140 that has anoffset tissue-receiving window 144. A moveable electrode 145 is adaptedto be driven by a motor drive unit 148 in handle 108 (see FIG. 1) sothat the longitudinal portion 149 of the electrode 145 sweeps across thewindow 144 from side to side to electrosurgically resect tissue that iscaptured in the window 144. The targeted tissue can be suctioned intoand captured in window 144 by means of a negative pressure source oroutflow pump 150 in controller 155 that communicates with a tissueextraction channel 158 extending through the device 105 and terminatingin the window 144.

More in particular, referring to FIGS. 2 and 3, the configuration of theoffset housing 140 is adapted to perform multiple functions. First, theoffset housing 140 positions the window surface WS (within curved planeP indicated in FIG. 2) outwardly from the outer surface 160 of shaft 110which then allows the window surface WS to be fully visible through anendoscope 130 or other viewing means that would be introduced parallelto the device shaft 110 (see FIG. 4A). For example, FIG. 4A is aschematic view of the working end 115 with working surface WS in contactwith targeted tissue T. As can be seen in FIG. 4A, the endoscope 130 ispositioned with the field of view FV directly aligned with the workingsurface WS thus allowing optimal viewing of the tissue resectionprocess.

In contrast, FIG. 4B shows a working end 115′ of a conventional dualsleeve tubular cutter having a window surface WS' which when pressedagainst an organ prevents endoscopic vision of the interface between thetubular cutting edge and the tissue T during a resection procedure.

Second, the offset housing 140 is adapted for resecting tissue to agreater depth in a localized region of an organ, rather than resectingsurface tissues over a broad area. More in particular as shown in FIG.5, the offset portion 170 of housing 140 can be pushed into tissueperpendicular to axis 112 of the probe shaft 110. Thus, as shown in FIG.5, the offset housing 140 can be used to resect tissue deep into in alocalized region that would not be possible with a resecting devicehaving the configuration shown in FIG. 4B.

FIGS. 2 and 3 illustrate the asymmetric or offset dielectric housing 140that can comprise a ceramic material such as zirconium oxide, aluminumoxide or similar materials as is known in the art. In FIGS. 2-3, it canbe seen that window surface WS is offset from the shaft surface 160 by apredetermined dimension D which can be from 2 mm to 8 mm and in oneembodiment comprises a 5 mm offset.

As can be further be seen in FIGS. 2-3, the width W of the windowsurface WS around at least portions of the perimeter of the window 144is a limited dimension, for example less than 3 mm, or less than 2 mm orless than 1 mm. which allows the offset portion 170 of housing 140 to bepushed into tissue perpendicular to the device axis 112 as the electrode145 sweeps across the window 144.

Referring to FIGS. 2-3, one variation of resecting device 105 has anelectrode 145 that can be tungsten or stainless steel wire that withelectrode portion 149 adapted to sweep across the window 144 at anysuitable rate, for example from 1 cycle per second (CPS) to 50 CPS ormore. In FIG. 3, it can be understood that the electrode 145 has anelongated proximal shaft portion 176 that extends into handle 108 of thedevice (FIG. 1). The proximal end of electrode 145 is operativelycoupled to a motor drive unit 148 and a suitable mechanism or controlleris provided to rotate the elongated electrode shaft portion 176 in anarc to resect tissue.

As can be understood from FIGS. 2-3, the electrode portion 149 movesback and forth akin to a windshield wiper across window 144 in theoffset housing 140. A number of mechanisms can be used to effectuate thedesired movements of the electrode, or the motor drive 148 simply can becontrolled by software to move in intermittent clockwise andcounter-clockwise directions. In one variation, the elongated proximalportion 176 of the electrode 145 will twist over its length and thus themotor drive 148 can be adapted to rotate the electrode shaft in an arcwith radial angle which is greater than the window's comparable radialangle or arc. Thus, the electrode portion 149 can be expected to moveback and forth entirely across the window even when meeting some tissueresistance by compensating for some twisting that is allowed in theproximal electrode shaft portion 176. In one variation, the motor driveunit can be adapted to over-rotate the electrode shaft portion 176 atits proximal end by a selected amount which can be from 10° radialmotion to 90° radial motion to compensate for twisting of the electrodeshaft portion to insure that electrode portion 149 sweeps entirelyacross the surface of window 144.

In general, the window 144 in housing 140 can be configured to have aradial arc relative to the electrode shaft 176 ranging between 30° and180°. In one variation of housing 140′ shown in FIG. 6, it can be seenthat the electrode portion 149 has a range of motion that extends acrossthe radial dimension of the window 144 to ensure that any tissuecaptured in the window is resected as the electrode portion 149 passesthe window edges 182 a and 182 b to function like a shear or in ascissor-like manner. The electrode portion 149 moves over ledges 186 aand 186 b on either side of the housing 140′ and can bump into surfaces190 a and 190 b. By bumping into the surfaces 190 a and 190 b, any overrotation in the electrode shaft 176 to accommodate twisting as describedabove can limit the rotation of the electrode portion in the housing140′. Further, in FIG. 6, it can be seen that the distal tip 192 ofelectrode portion 149 extends distally beyond window 144 and onto distalledge 194 in the housing 140′ to ensure tissue is resected by theelectrode in the distal window region.

Now turning back to FIG. 1, it can be understood that the resectingdevice 105 and endoscope 130 can be used with introducer sleeve assemblyor sheath 102. As shown in FIG. 1, the introducer assembly 102 has aproximal handle body 202 with a connector 204 that is adapted to coupleto connector member 205. The connector 205 is adapted to couple aconduit 206 to controller 155 and provide within a single cable thefollowing: (i) a first lumen communicating with the fluid outflow pump150, (ii) a second lumen communicating with a fluid inflow pump 225, and(iii) a third lumen communicating with a pressure sensor positioned inthe controller 155 or in or near the connector 205. As can be seen inFIG. 1, the introducer sleeve 102 can also accommodate an endoscope 130.Thus, the introducer sleeve 120 can be assembled with the endoscope 130(and without the resection device 105) and coupled by connector 205 tothe controller 155 to provide an inflow of irrigation fluid from fluidsource 226, and outflow of irrigation fluid to collection reservoir 228together with pressure sensing to allow the assembly to be used in adiagnostic procedure prior to a tissue resection procedure. In otherwords, the introducer sleeve 102 can function as a ‘continuous flow’optical introducer for use in trans-urethral access to a targeted sirein the prostate or bladder.

After the introducer sleeve assembly 102 is used for an initialdiagnostic procedure, the endoscope 130 can be removed from the assembly102 and connector 205 can be disconnected from handle body 205.Thereafter, the sleeve portion 240 (see FIG. 1) of introducer assembly102 can be detached from proximal handle body 204 with the sleeveportion 240 remaining in the patient. Next, the endoscope 130 andconnector 205 can be assembled with the resecting device 105 and thephysician can insert the resecting device 105 through the sleeve portion240 remaining in the patient to access the targeted site. The resectingdevice 105 and sleeve portion 204 in combination then provide lumens asdescribed above for fluid inflows, fluid outflows and direct pressuresensing through lumens in connector 205.

Now turning to FIG. 7A, a perspective view of a distal ceramic housingof a working end 246 similar to that of FIG. 6 is shown. In thisvariation, the distal tip 248 of the moveable electrode 250 isconfigured to be constrained within a constraining slot or channel 252.In other words, the distal electrode tip 248 is not free-floating as inthe variation of FIG. 6. It has been found that an electrode with afree-floating distal tip can be caught by tissue and be lifted away fromthe ceramic housing 255. Thus, in this variation the distal electrodetip 248 is constrained and cannot be tangled with tissue or lifted awayfrom the ceramic housing and window 260. The variation of FIG. 7Aillustrates an arcuate slot or channel 252 that limits the movement ofthe electrode 250. In all other respects, the working end functions asdescribed previously. Further, the distal electrode portion 262 andchannel 252 can be configured to allow the electrode to pass over theedges 264 a and 264 b of the window 260 as described above.

FIG. 7B shows another variation of working end 266 in which theelectrode 270 has a distal tip 272 that is constrained in a pivot orbore indicated at 274. In this variation, it can be seen that theelectrode 270 has a U-shape with the distal tip 272 aligned with theelectrode shaft portion 275 to allow the active electrode portion 277 tomove from side to side relative to window 260 as described previously.

In another aspect of the invention shown in FIGS. 7A-7B, the electrodeshaft portion 275 comprises a tubular member 280 which can comprise ametal hypotube, such as stainless steel or a similar material. In aprevious variation as shown in FIG. 6, the electrode shaft portioncomprised a wire element which could potentially twist to an unwanteddegree when the electrode engaged dense tissue, for example. In thisvariation, it has been found that a metal hypotube with a suitable wallthickness can resist twisting when the electrode is being moved andengaging dense tissue. In one variation, the wall thickness of thetubular member 280 can be at these 0.005″ or at least 0.010″.

In general, a tissue resecting device corresponding to the inventioncomprises an elongated member extending along a longitudinal axis to adistal portion having a window communicating with an aspiration source,an electrode having an electrode shaft with a central axis extendingwithin the elongated member to an electrode working end wherein aportion of the electrode working end is offset from said central axis,and a motor configured to rotate the electrode shaft to cause theelectrode working end to move relative to the window wherein theelectrode shaft comprises a tubular member adapted to resist twisting ofsaid shaft during motor driven movement thereof. Further, the tubularmember can comprise a metal tube with an insulative outer surface layer282. The tissue tubular member can be a stainless steel tube with theinsulative outer surface layer comprising a heat shrink polymer.

In one variation, the electrode's working end has a profile that issubstantially smaller than the area of the window to thereby permitfluid aspiration around the electrode working end at all times throughthe window as the electrode is moving relative to the window. Thisallows the negative pressure source to draw the tissue into the windowinterface, and maintains the tissue in the interface as the electrodecuts and extracts the resected tissue. In one variation, the electrodeworking end is motor driven and moves at a rate of equal to or greaterthan 1 CPS relative to the window, or equal to or greater than 10 CPSrelative to the window. As described previously, the electrode workingend can be offset radially outward from the shaft assembly by at least 2mm or by at least 4 mm.

In another aspect of the invention, the tissue resecting devicecomprises an elongated member extending to a distal housing having atissue-receiving window, a moveable electrode configured to move acrossthe window, and a motor configured to move the electrode wherein adistal tip of the electrode moves in a constraining channel in thehousing. In another variation, the tissue resecting device comprises anelongated member extending to a distal housing having a tissue-receivingwindow, a moveable electrode configured to move across the window; and amotor configured to move the electrode wherein a distal end of theelectrode is non-free floating or pivots in a pivot channel.

FIG. 8 is a perspective view of a tissue resecting device 400 thatincludes a handle 402 carrying a motor drive 405 and a shaft assembly410 extending from the handle to a working end 415, for examplecomprising a ceramic or other housing 418 (FIGS. 9A and 9B) having atissue-receiving window 420 and a motor-driven electrode 425 that isadapted to move across the window 420 as described previously. Theworking end 415 is coupled to sleeve 428 which is adapted for manual ormotor-driven reciprocation within shaft assembly 410. More inparticular, this variation of device 400 provides the motor drive 405for moving the electrode 425 in the working end 415 which is similar tothat of FIG. 7A. Further, in this embodiment, the device 400 canoptionally utilize the motor drive to reciprocate the working end 415relative to the shaft assembly 410 contemporaneously or alternatinglywith the movement of the electrode 425 relative to the window 420 asdescribed previously. Alternatively, the device 400 carries a firstmotor for moving the electrode 425 relative to the window 420 in thehousing 418 and a second motor (not illustrated) for reciprocating theworking end 415. In another variation, the single motor 405 can beadapted to perform both the electrode movement and the working endreciprocation. As can be seen in FIGS. 10A-10B, the handle 402 allowsfor manual retraction and extension of the working end 415 within theshaft assembly 410 by movement of an actuator grip 430 relative tostationary grip portion 432 of handle 402.

FIG. 9A is a perspective view of the working end 415 of the device 400of FIG. 8 showing an endoscope 440 carried with an outer sleeve 442 ofthe shaft assembly 410. The working end 415 carried by sleeve 428 issimilar to that of FIGS. 2, 3, and 6 described previously, but couldhave any of the constructions described previously. The endoscope 440has optics 444 which provide a field of view 445 which can encompass theworking end 415 on the elongated member 428. A light emitter 446 isshown in the distal end of the endoscope 440. FIG. 9B is a perspectiveview of the working end of the device of FIG. 9A from another angle.

FIGS. 10A and 10B are side views of the tissue resecting device 400 ofFIG. 8 illustrating reciprocation of the sleeve 428 and working end 415within shaft assembly 410 and relative the stationary grip portion 432of handle 402. FIG. 10A shows the sleeve 428 and working end 415 at adistal end of an extending stroke relative to the shaft assembly 410 andhandle 402, and FIG. 10B shows at the working end 415 and sleeve 428 ata proximal end of a retracting stroke relative to the handle. In thisvariation, the working end 415 and sleeve 428 are adapted to reciprocatewhile the endoscope 440 remains stationary in the handle 402. Inalternative embodiments (not shown), the working end 415 and sleeve 428may be configured to axially reciprocate together with the endoscope 440in the shaft assembly 410.

FIG. 11 illustrates a method according to the invention showingretracting and extending strokes of the working end 415 and sleeve 428wherein a controller 450 activates and de-activates a negative pressuresource 455 and causes delivery of RF current from an RF source 460 tothe moveable electrode 425 in different portions of the retracting andextending strokes.

The methods of the present invention can employ any tissue resectingdevice having a moveable working end such as working end 415 andmoveable sleeve 428 described previously, extending along a longitudinalaxis to a distal housing 418 and having a window, such as window 420 incommunication with a remote negative pressure source 455, a moveableelectrode 425 configured to move relative to the window 420 and at leastone motor 405 adapted to move the electrode across the window 420 andoptionally to reciprocate or otherwise move the working end 415 in anaxial stroke. The motor drive 405 can be adapted to rotationallyoscillate the electrode at any of the rates set forth previously herein,often being greater than 1 CPS (cycles per second) relative to thewindow. Optionally, the motor can be used to axially reciprocate thesleeve 428 and working end 415 at least once every 2 seconds or at leastonce per second relative to the handle.

In another variation, the tissue resecting device is coupled to acontroller 450 that is configured to operate (1) the RF source 460coupled to the electrode, (2) the negative pressure source 455, and (3)the at least one motor 405 for moving the electrode 425 and optionallyfor reciprocating the working end 415 within the shaft assembly 410.Further, the controller may be adapted to control the at least one motordrive to stop movement of the electrode 425 in a selected positionrelative to the window 420. More in particular, the controller can beadapted to selectively stop the electrode 425 in the center of thewindow 420 or at an edge of the window.

In still further variations, the controller 450 is adapted to controlthe at least one motor drive 405 to provide a single movement or cycleof the electrode 425 back and forth across the window 420. In yetanother variation, the controller 450 is adapted to control the at leastone motor to stop movement of the working end 415 and sleeve 428 in aselected axial position relative to the shaft assembly 410.

Referring again to FIG. 11, the controller 450 can be adapted to controlthe at least one motor drive 405 to provide a single movement of theshaft assembly in a retracting and extending stroke. In anotherembodiment, the controller 450 is configured to operate the RF source460, the negative pressure source 455 and the at least one motor drive405 contemporaneously. For example, the controller 450 can be adapted tomodulate the negative pressure source 455 in response to movement of theworking end, or activate or de-activate the RF source in response tomovement of the working end, or modulate the negative pressure source inresponse to movement of the electrode 425 relative to the window, oractivate or de-activate the RF source in response to movement of theelectrode 425 relative to the window 420 in ceramic body 418. Further,the RF source 460 can be configured to deliver a cutting currentwaveform or a coagulation waveform to the electrode.

Referring to FIG. 11, a method of resecting tissue according to thepresent invention comprises providing an elongate shaft assembly, suchas assembly 410, having a longitudinal axis and including areciprocating sleeve 428 carrying a working end 415 comprising a distalhousing 418 having an electrode 425 proximate a window 420 in thehousing. The sleeve 428 and working end 415 are moveable relative to astationary portion of the handle 402 with a retracting stroke and anextending stroke. The working end 415 is positioned against a targetedtissue site, and a negative pressure source communicating with thewindow 420 in the working end 415 is activated. An RF source isactivated to deliver RF current to the electrode 425 as the motor drivemoves the electrode across the window, and the working end 415 is movedin a retracting stroke to thereby resect tissue while the negativepressure source remains activated to draw tissue into contact with thewindow 420. The method may further comprise de-activating the negativepressure source, the motor drive and typically also the RF source at theproximal end of the retracting stroke, typically via the controller.Subsequently, the method may comprise commencing the extending strokewith the negative pressure source de-activated and with the RF sourcede-activated. As can be seen in FIG. 11, the controller activates thenegative pressure source during a terminal portion of the extendingstroke to again draw tissue into contact with the window 420 to preparefor the following retracting stroke which then again resects tissue withthe energized, oscillating electrode 425.

As can be understood from the steps of the method described above,variations of the timing of activation and de-activation of the negativepressure source and RF current delivery are possible. In anothervariation, the electrode can be energized and oscillated to resecttissue in both the retracting stroke and the extending stroke with thenegative pressure source continuously activated.

In another variation, the electrode can be stopped in a selectedposition in the window, and a coagulation current can be delivered tothe electrode for coagulating tissue. Alternatively, the cutting currentwaveform can be delivered to the stationary electrode for ablatingtissue.

FIGS. 12A-12B illustrate another aspect of the present invention whereinthe controller 450 and RF source 460 can be adapted to deliver an RFcurrent with a cutting waveform to the electrode 425 or an RF currentwith a coagulation waveform to the electrode in various modes ofelectrode movement or when the electrode is stationary relative to thewindow. FIGS. 12A-12B are sectional views of the working end of FIG. 9Aor FIG. 11 interfacing or engaging with tissue 480.

In general, a method of treating prostate tissue comprises providing atreatment device with a shaft extending along a longitudinal axis to adistal portion having a window 420 in ceramic body 418 communicatingwith a negative pressure source and a motor driven electrode 425 adaptedto move relative to the window, positioning the window in an interfacewith targeted tissue 480, operating in a first mode with a cuttingwaveform delivered to the electrode while activating the motor to movethe electrode to resect tissue 480 (FIG. 12A) and thereafter operatingin a second mode with a coagulation waveform delivered to the electrode425 after de-activating the motor to stop the electrode 425 in aselected stationary position to coagulate tissue indicated at 484 (FIG.12B). Further, the positioning step can be preceded by the step ofintroducing the shaft in a trans-urethral approach into a patient'sprostate. The first mode includes sweeping the electrode 425 across thewindow 420 to resect tissue interfacing the window as shown in FIG. 12A.The electrode 425 can be adapted to sweep across the window from side toside, or in another variation can move distally and proximally in thewindow 430.

In the first mode, the electrode 425 can move at a rate of greater than1 CPS relative to the window 430. Further, operating in the first modeincludes activating the aspiration source within a first negativepressure range to draw tissue against or into the window and to aspiratefluid and resected tissue through the window. Operating in the secondmode includes activating the aspiration source within a second negativepressure range to aspirate fluid through the channel in the shaft. Whenoperating in the first and second modes, a controller is utilized toactivate and de-activate the motor, the RF source and the negativepressure source in a selected manner.

In another method, the controller can operate the motor and RF source ina third mode to delivering a coagulation waveform while activating themotor to move the electrode at less than 100 CPS.

In another method, the controller can operate the motor and RF source ina fourth mode delivering a cutting waveform after de-activating themotor to stop the electrode in a selected stationary position.

When the device is operated in a mode with a stationary electrode, theselected stationary position of the electrode is substantially centeredin the window. Such a centered position allows for aspiration of fluidaround both sides of the electrode through the window which cools theelectrode in the coagulation mode and remove bubbles when the cuttingcurrent is used to ablated tissue.

In general, a tissue resecting device comprises an elongated shaftextending along a longitudinal axis to a distal portion having a windowcommunicating with an aspiration source, a wire-like electrodeconfigured to move relative to the window, an RF source configured todeliver RF current in a cutting waveform and a coagulation waveform tothe electrode, a motor configured to move the electrode, and acontroller configured to operate the motor and RF source in a first modedelivering a cutting waveform while activating the motor to move theelectrode, and in a second mode delivering a coagulation waveform afterde-activating the motor to stop the electrode in a selected stationaryposition. In this variation, the electrode has a surface area smallerthan the window area to permit fluid aspiration around the electrode andthrough the window in the first and second operating modes.

When operating in the first mode, the controller can activate theaspiration source within a first negative pressure range. When operatingin the second mode, the controller can activate the aspiration sourcewithin a second negative pressure range.

When operating in a third mode, the controller can be configured tooperate the motor drive and RF source to deliver a coagulation waveformwhile activating the motor to move the electrode at less than 50 CPS.

When operating in a fourth mode, the controller can be configured tooperate the motor and RF source to deliver a cutting waveform afterde-activating the motor to stop the electrode in a selected stationaryposition, for example in the center of the window.

As can be seen in FIGS. 9A, 9B and 11, the distal portion of the sleeve428 includes a dielectric body or housing 418 having the window 420therein. Typically, the housing is a ceramic material which can beselected from the group consisting of yttria-stabilized zirconia,magnesia-stabilized zirconia, ceria-stabilized zirconia, zirconiatoughened alumina and silicon nitride. In other variations, thedielectric body can be a polymeric material.

The motor drives shown in FIGS. 8, 10A and 10B can be disposable ordetachable and thus re-usable.

As can be understood from the steps of the method described above,variations of the timing of activation and de-activation of the negativepressure source and RF current delivery are possible. In anothervariation, the electrode can be energized to resect tissue in both theretracting stroke and the extending stroke with the negative pressuresource continuously activated.

In another variation, the electrode can be stopped in a selectedposition in the window, and a coagulation current can be delivered tothe electrode for coagulating tissue. Alternatively, the cutting currentwaveform can be delivered to the stationary electrode for ablatingtissue.

FIG. 13 illustrates an alternative embodiment of a resection device 500that is similar to that of FIGS. 1-2 except that an outer introducersheath or sleeve is integrated into the resection device and is not aseparate component as in the variation of FIGS. 1-2.

As can be seen in FIG. 13, the resection device 500 again has a handle502 coupled to an elongated shaft assembly 505 extending about alongitudinal axis 506. The handle 502 has a stationary grip portion 507and a movable grip 508 that is adapted to reciprocate a shaft 510 andworking end 512 of the resection component 515 (see FIG. 15) which isthe same as in previous embodiments. Again, the working end 512 of theresection component 515 includes an RF electrode is 518 that adapted tosweep across an open window 520 in a dielectric housing 524 which can bea ceramic or a polymeric material (FIG. 15). An aspiration channel 525is provided in the shaft 510 and working end 512 of the resectioncomponent 515 to remove tissue chips from the working end 512. Anegative pressure source 540 again is coupled to the handle 502 as inprevious embodiments for extracting tissue through the aspirationchannel 525 of the resection component (FIG. 13). As will be describedbelow, the negative pressure source 540 also communicates with aseparate flow pathway 592 in the shaft assembly 505 (see FIG. 17).

An endoscope 545 is adapted to be inserted into an endoscope channel 546in the device 500 (see FIG. 14A). In the embodiment shown in FIG. 13, adedicated pressure sensing channel 548 is also provided in the elongatedshaft 505 as in previous embodiments (see FIG. 16).

As can be understood in FIGS. 14A-14B, the resection device 500 has anintegrated introducer sleeve assembly 550, whereas the previous versionshave an independent introducer sleeve component (see FIGS. 1-2) In FIG.14A, the introducer sleeve assembly 550 comprises an outer introducersleeve or tubular member 552 and an inner sleeve 555 described furtherbelow. FIG. 13 shows the outer sleeve 552 fixed to the handle 502 whichextends to a distal end 558 which comprises a resilient structure 560that is movable or deformable between a first tapered, rounded-noseshape or similar configuration (FIG. 14A) for introduction through abody passageway and a second cylindrical shape or configuration (FIG.14B) that allows for the endoscope 545 and resection component 515device to be advanced into or through the sleeve assembly 550 andresilient structure 560. The outer introducer sleeve 552 can be athin-wall stainless steel material with a diameter ranging from about 6mm to 15 mm.

In FIG. 14A, which is an enlarged view of the resilient structure 560 isits tapered position, it can be understood that the structure 560 is ina repose, or non-tensioned and contracted configuration. FIG. 14B showthe distal end 558 of the sleeve assembly and resilient structure 560 ina tensioned and expanded configuration.

In FIG. 14A, it can be seen that the outer introducer sleeve 552 has adistal portion 565 that is fabricated of a spring material that definesa plurality of spring struts 566 and openings 568 to allow movement ofthe structure 560 from the repose position of FIG. 14A to the tensionedposition of FIG. 14B. In one variation, the struts 566 define triangularshapes around openings 568 and the struts can range in number from about4 to 20 or more. In a typical embodiment, the struts 566 are fabricatedby cutting a thin-wall tubing of a spring material (typically but notnecessarily formed integrally with the outer introducer sleeve 552) andthen forming the struts 566 into the repose shape as shown in FIG. 14A,e.g. by heat treatment over a mandrel or the like. In anotherembodiment, the struts can be formed from a round, flat or ovalspring-type wire elements. The wire elements then can be welded orotherwise bonded to the distal end 570 of the rigid sleeve portionindicated at 572.

As can be further seen in FIGS. 14A and 14B, the resilient structurefurther comprises an elastomeric material 575, such as silicone, moldedover the struts 566. The distal end 570 of the rigid sleeve portion 572is provided with apertures 578 therein for engaging the over-moldedpolymer. In one variation, the polymer 575 is a substantiallytransparent material to allow viewing therethrough. In other variations,the polymer material may be opaque or non-transparent. The tapered shapeof the resilient structure 560 in FIG. 14A is configured with a distalopening 580 that has a selected dimension that may range from 10% to 50%of the diameter of the opening 580′ of the structure 560 in its expandedshape as shown in FIG. 14B. The dimension of the distal opening 580 inthe tapered position of FIG. 14A is selected to allow viewing throughthe endoscope 545 during insertion of the distal end of the device 500through a body passageway.

As can be seen in FIGS. 14A and 14B, in one variation the endoscope 545can be in a proximal position when the resilient structure 560 is in itscontracted, tapered configuration and then the endoscope can be movedistally when the resilient structure 560 is in its open, tensionedposition as shown in FIG. 14B.

FIG. 17 shows the mechanism for moving the resilient structure 560 fromthe tapered, contracted position of FIG. 14A to the cylindrical positionof FIG. 14B. It can be seen that the introducer sleeve assembly 550includes the inner sleeve 555 that is adapted to move axially from aretracted position to the extended position as shown in FIGS. 14B and17. In other words, the distal movement of the inner sleeve 555 willcontact the inner surfaces 582 of the struts 566 and elastomericmaterial 575 in the tapered position of FIG. 14A and then push thestruts 566 outwardly and stretch the elastomeric material 575 to providethe cylindrical shape of FIGS. 14B and 17 as the inner sleeve 555 isfully extended. FIG. 14B shows that the stroke ST of inner sleeve 555can range from about 5 mm to 20 mm in a typical embodiment.

Returning to FIG. 13, the mechanism for moving the inner sleeve 555 fromits retracted position to its extended position of FIG. 17 can beunderstood. In FIG. 13, it can be seen that a rotating actuator element585 is provided which has a cam surface which interfaces with the innersleeve 555 to move such inner sleeve 555 axially back and forth uponrotation of the finger tab 586. Thus, the finger tab 586 can be designedto move from about 45° to about 90° to move the inner sleeve 555 in thedesired stroke ST as shown in FIG. 14B.

Now turning again to FIG. 14A, in another aspect of the invention, theouter introducer sleeve 552 is configured with a plurality of ports 590which communicate with the annular space 592 between the outer sleeve552 and the inner sleeve 555 (see FIG. 17). The annular space 592between the inner and outer sleeves 552, 555 communicates with thenegative pressure source 540 and thus provides an outflow path fordistention fluid which is independent of the flow channel through theresection component 515 (see FIG. 15). In the variation shown in FIGS.14A and 16, the device shaft 505 has a fluid inflow channel 595 thatcomprises the space outward of the shaft 510 of the resecting component515 and the sleeve 600 carrying the pressure sensing channel 548 as inprevious embodiments.

In FIG. 17, it can be seen that the distal portion of the inner sleeve555 includes a polymer (e.g., silicone) over-molded portion 605 whichserves two purposes. First, the polymer over-molded portion 605 has anannular ridge 608 which interfaces with the inner surfaces 582 of thestruts 566 and elastomeric material 575. The radial height RH of theannular ridge 608 thus provides the annular space 592 between the outersurface of the inner sleeve 555 and the inner surface of the outersleeve 552 through which distention fluid may be aspirated after flowingthrough the multiple ports 590 in the outer sleeve 552. Secondly, theannular ridge 608 of the over-molded polymer portion 605 can be adaptedto seal the interface between the inner sleeve 555 and the resilientstructure 560 so that distention fluid is not aspirated through thedistal opening 580′ of the resilient structure 560 in its cylindricalshape as shown in FIG. 17. This aspect of the invention may be useful toprevent and interference with inflows of distention fluid through inflowchannel 595 (see FIG. 16). Rather, the variation shown in FIG. 17 allowsfor fluid inflows to exit the resilient structure 560 and opening 580′around the distal end of the endoscope 545 which provides the advantageof clearing the visual field distal to the endoscope 545 to therebymaintain clear viewing. If both inflows and outflows were adjacent toone another in the interior of the resilient structure 560, the clearingof the visual field with fluid inflows could be impaired. In anothervariation (not shown), the annular ridge 508 could be provided withnotches to allow a portion of the fluid outflows into annular space 592to flow through the distal opening 580′. In a typical embodiment, thenegative pressure source 540 would communicate with both the annularspace 592 and the aspiration channel 525 in the resection component 515.

FIG. 15 shows the introducer sleeve assembly 550 and the resilientstructure 560 in its expanded position with the working end 512 of theresecting component 515 advanced through the distal the opening 580′ inthe resilient structure 560. The working end 512 of the resectingcomponent 515 is similar to the previously described embodiments.

FIG. 18 shows the distal end of the introducer sleeve assembly 550 andresilient structure 560 and the working end of the resection component515 from a different angle. In this variation, it can be seen that thewindow 520 of the working end defines a surface S or curved plane acrosswhich the electrode 518 oscillates and cuts tissue. In this variation,the window 520 has a substantially large surface area SA for interfacingwith targeted tissue, wherein said surface area can range from 5 mm² to40 mm².

FIG. 19 shows the working end 512 of the resection component 515 from adifferent angle and further shows the stroke SK of the resectingcomponent 515 and the surface area SA of the window 520. The stroke SKof the resecting component 512 can range from 5 mm to 20 mm, andtypically is from 8 mm to 15 mm. Thus, it can be understood that thearea of targeted tissue that interfaces with the electrode 518 over thestroke SK of the resecting component 515 is substantially large, forexample from 25 mm² to 800 mm². Thus, the oscillating electrode 518 in atypical procedure can provide a tissue removal rate that is greater than5 grams per minute, and often is greater than 10 grams per minute.

Now turning to FIG. 20, another introducer sleeve assembly 550 is shownwith a different variation of a resilient structure 560′. In thisvariation, the resilient structure 560′ again has spring-type metalelements 620 extending from the distal end 570 of the rigid sleeveportion 572. The metal elements 620 or struts have a linear shape ratherthan the triangular as in the previous embodiment. Such elements 620 areflexible to move and deform between the tapered shape as shown in FIG.22 and an expanded, cylindrical shape that stretches the elastomericmaterial 575′ as in FIG. 14B. In one variation, the metal elements 620have apertures 622 therein or other features to engage the over-moldedelastomeric material 575′. It is necessary to secure the over-moldedelastomer to the metal elements 620 to prevent axial stretching of theresilient structure 560′ as the inner sleeve 555 (FIG. 17) is advanceddistally to its extended position that might otherwise axially stretchthe elastomer 575′. In use, the resilient structure of FIG. 20 can beactuated from the tapered shape of FIG. 20 to its open, cylindricalshape by extension of inner sleeve 555 as shown previously in FIG. 17.The open shape alternatively can be oval, elliptical, polygonal or anycombination thereof which is enlarged to allow for endoscopic viewingthe passage of the resection device therethrough.

FIG. 21 shows another variation of a resilient structure 560″ which issimilar to that of FIG. 20 except that there are no spring-type metalelements extending distally from the distal end 570 of the rigid sleeveportion 572. In this variation, the entire resilient structure 560″ is amolded polymer such as silicone that includes non-stretchable interiorribs 628 that prevent the resilient structure 560″ from being stretchedaxially when the inner sleeve 555 is extended. In this variation, theinner sleeve 555 would have a polymer over-molded tip section similar tothat shown in FIG. 17. However, in this embodiment, an annular ridgesimilar to ridge 608 and FIG. 17 would be provided with notches thereinto interface with each of the non-stretchable ribs 628. In all otherrespects, the variation of FIG. 21 would function as the variation shownin FIGS. 14A and 14B.

FIG. 22 is another variation of resilient structure 640 that is similarto that of FIG. 21 except that the structure 640 is asymmetric with thedistal opening 644 being off-center relative to the central axis of thesleeve assembly 550. In this variation, the distal opening 644 would beconfigured to be optimally aligned with the field of view of theendoscope 545 so as to improve the viewing angle VA through the opening644 when the resilient structure 640 is in the tapered position of FIG.22. This variation would be moved from the tapered shape of FIG. 22 toan open, cylindrical shape by extending the inner sleeve 555 asdescribed previously.

While the introducer sleeve assemblies of FIGS. 14A-14B and FIGS. 20-22have been described as integrated with a resection device 515, it shouldbe appreciated that the concentric sleeve assembly 550 and taperedresilient structure 560 can comprise an independent introducer devicewith an endoscope 545 for visual access to any body cavity or potentialspace with such an introducer and optional irrigation.

While the variations of the expandable distal end are described above asincluding an elastomeric material, it is also possible to provide anintroducer distal end that has overlapping metal leaves similar to thatof a camera shutter that can be moved from a tapered shape to anon-tapered shape. Further, in various embodiments that utilize metalstruts embedded in an elastomeric material, such metal struts may be ofa spring material and be tensioned in either the tapered or non-taperedshape with the elastomeric material responsible for providing the reposetapered shape of the structure.

FIGS. 23 and 24 illustrate another variation which is similar to that ofFIGS. 14A, 14B and 15 except the distal end of sleeve assembly 550′carries a deformable elastomeric portion 650 that can be actuated to inan expanded configuration to function as a seal in a body lumen. As canbe understood from FIGS. 23 and 24, the extension of the inner sleeve555′ within outer sleeve 552′ causes the elastomeric portion 650 tobuckle upward to provide and annular sealing structure. It can be seenthat inner sleeve 555′ is coupled to an outer collar 655 that isattached to the proximal end 656 of the elastomeric portion 650. In onevariation, the elastomeric portion 650 is an integral part of theresilient structure 560. The inner sleeve 555′ is coupled to the outercollar 655 by elements 670 that slide in slots 672 in the outer sleeve552′. Thus, the movement of the inner sleeve 555′ is adapted to causeboth movement of the resilient structure 560 from the tapered shape tothe non-tapered shape (FIGS. 14A-14B) as well as movement of theelastomeric component 650 to the expanded shape of FIGS. 23-24 forsealing a body passageway.

In another variation, some or all of the inner and outer surfaces ofsleeves and structures in the interior of the sleeve assembly 550 asshown in FIGS. 14A, 16 and 17 can be coated with a dielectric materialthat can withstand high temperatures so as not to interfere with theoperation of the resection device 515.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A medical device comprising: an elongated tubularmember having a proximal end, a distal portion, and a central lumenextending from the proximal end to a distal port in the distal portion;and a frame structure coupled to the distal portion of the elongatedtubular member, said frame structure configured to support the distalportion of the elongated tubular member in each of a tapered shape and anon-tapered shape.
 2. The medical device of claim 1, wherein the taperedshape is conical and the non-tapered shape is cylindrical.
 3. Themedical device of claim 2, wherein frame structure is configured to openthe distal portion to its non-tapered shape in response to a radiallyoutwardly acting force and to resiliently close the distal portion toits tapered shape in the absence of a radially outwardly acting force.4. The medical device of claim 3, wherein the frame structure comprisesstruts and the distal portion of the elongated tubular member comprisessaid struts embedded in an elastomeric material.
 5. The medical deviceof claim 4, wherein the elastomeric material is substantiallytransparent.
 6. The medical device of claim 3, wherein the elongatedtubular member comprises an outer tube and an inner tube carried in aninterior lumen of the outer tube, wherein the inner tube is configuredto axially translate from (a) an axially retracted position wherein theframe structure is resiliently closed and the distal portion of theelongated tubular member is in its tapered shape to (b) an axiallyextended position wherein the frame structure is open and the distalportion is in its non-tapered shape.
 7. The medical device of claim 6,wherein the interior lumen transitions to a central passageway in saiddistal portion which extends to the distal port.
 8. The medical deviceof claim 7, wherein the central passageway in said distal portion tapersto a distal port diameter less than a diameter of the interior lumenproximal of the distal portion when said distal portion in its taperedshape.
 9. The medical device of claim 7, wherein the central passagewayin said distal portion has a constant diameter equal to a diameter ofthe interior lumen proximal of the distal portion when said distalportion in its non-tapered shape.
 10. The medical device of claim 1,wherein the elongated tubular member comprises a rigid outer tube and arigid inner tube carried in an interior lumen of the outer tube andwherein the distal portion comprises a reinforced elastomeric tubularextension of the outer tube, wherein said reinforced elastomeric tubularextension has a conical.
 11. The medical device of claim 1, wherein theframe structure comprises a shape memory material having a conical shapememory and expandable to a cylindrical shape when subjected to aninternally applied radially outwardly acting force.
 12. The medicaldevice of claim 11, wherein the shape memory material comprises at leastone of a group consisting of a zig-zag ring, a serpentine ring, aplurality of axial struts joined to a base ring, plurality ofunconnected axial struts, and a plurality of axially extending ribsattached to a distal end on the outer tube.
 13. The medical device ofclaim 1, wherein the central lumen of the elongated tubular member isconfigured to accommodate at least one of a group consisting of anendoscope and an elongated shaft of a treatment device.
 14. The medicaldevice of claim 1, wherein the elongated tubular member is configured tobe connected to a negative pressure source.
 15. The medical device ofclaim 10, wherein an annular space between an inner surface of the outertube and an outer surface of the inner tube of the elongated tubularmember is configured to be connected to a negative pressure source,wherein the outer tube is perforated.
 16. The medical device of claim 1,wherein the tubular member includes at least one of the group consistingof an interior channel communicating with a fluid inflow source and aninterior channel communicating with a pressure sensor.
 17. The medicaldevice of claim 10, further comprising an actuator for moving the innertube between a retracted position and an extended position relative tothe outer tube.
 18. A medical introducer comprising: an outer tubehaving a proximal end, a distal end, and a lumen therebetween; anelastomeric sleeve extending distally from the distal end of the outertube, wherein said elastic sleeve tapers in a distal direction from thedistal end of the outer tube to a distal port; and a concentric innertube slidably received in the lumen of the outer tube, said inner tubebeing configured to move between a retracted position where the innertube does not engage the elastomeric sleeve and an extended positionwhere the inner sleeve engages the elastomeric sleeve to open theelastomeric sleeve to a non-tapered shape.
 19. The medical introducer ofclaim 18, wherein the elastomeric sleeve structure includesreinforcement structure to inhibit axial stretching as the inner tube ismoved between its retracted and extended positions.
 20. The medicalintroducer of claim 19, wherein the reinforcement structure comprisesdeformable struts coupled to a distal end of the outer tube.
 21. Themedical introducer of claim 20, wherein said deformable struts aremetal.
 22. The medical introducer of claim 19, wherein saidreinforcement structure comprises ribs molded into the elastomericsleeve.
 23. The medical introducer of claim 18, wherein the distal portin the elastomeric sleeve is concentrically aligned with a central axisof the outer tube.
 24. The medical introducer of claim 18, wherein thedistal port in the elastomeric sleeve is radially offset from a centralaxis of the outer tube.
 25. A system comprising: the medical introducerof claim 18; and a tool configured to be introduced through a lumen theconcentric inner tube.
 26. The system of claim 25, wherein the tool isselected from a group consisting of an endoscope, an RF surgical tool,27. The system of claim 25, wherein further comprising a fluid sourceconnectable to a lumen of the inner tube.
 28. The system of claim 25,further comprising a negative pressure source connectable to an annularspace between the outer tube and the inner tube.
 29. A medicalintroducer comprising: an outer tube having a proximal end, a distalend, and a lumen therebetween; a tapered elastomeric sleeve extendingdistally from the distal end of the outer tube; a circumferentiallyexpandable elastomeric sleeve disposed on the outer tube proximally ofthe tapered elastomeric sleeve; a concentric inner tube that isconfigured to move between a retracted position and an extendedposition; wherein the inner sleeve in its extended position (a) deformsthe tapered elastomeric sleeve structure from the tapered shape to acylindrical shape, and (b) deforms the circumferentially expandableelastomeric sleeve from a contracted cylindrical shape to an expandedannular shape.